Zicam Cold Remedy Soft Chews

Manufacturer
BestCo Inc.
Effective date
2016-02-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:07:32

Label at a glance#

ProductZicam Cold Remedy Soft Chews
Active ingredientZINC ACETATE, CAFFEINE, ZINC GLUCONATE
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each soft chew)

Zincum aceticum 2X

Zincum gluconicum 1X

Caffeinum 5X

OTC - PURPOSE SECTION

Purpose

Reduces duration and severity of the common cold

Helps restore mental alertness

INDICATIONS & USAGE SECTION

Uses

  • reduces duration of the common cold
  • reduces severity of cold symptoms: sore throat, stuffy nose, sneezing, coughing, nasal congestion
  • helps restore mental alertness when experiencing fatigue or drowsiness

WARNINGS SECTION

Zicam Cold Remedy was formulated to shorten the duration of the common cold and was not formulated to be effective for flu or allergies.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have a sensitivity to zinc or are allergic to zinc

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist or are accompanied by a fever or new symptoms occur

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • for best results, use at the first sign of a cold and continue to use until to use until symptoms completely subside
  • adults and children 12 years of age and older:
  • take 2 soft chews at the onset of symptoms
  • chew thoroughly before swallowing
  • repeat every 2-6 hours, not to exceed 4 doses in 24 hours. Take until symptoms are gone.
  • to avoid minor stomach upset, do not take on any empty stomach
  • do not eat or drink for 15 minutes after use. Do not eat or drink citrus fruits or juices for 30 minutes before or after use. Otherwise, drink plenty of fluids.
  • children under 12 years of age: ask a doctor before use.

OTHER SAFETY INFORMATION

Other information

  • store between 15-29C (59-84F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

cocoa powder, coconut oil, corn syrup, corn syrup solids, glycerin, natural and artificial flavors, purified water, soy lecithin, sucralose, sucrose

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Zicam Vitality SC 32ctZicam Vitality SC 32ct

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52642-232-322020-01-31C16284748780-19d75b9d0-b704-f424-e053-dadaa90a57ceZincum aceticum 2X Zincum gluconicum 1X Caffeinum 5X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52642-232-32Zicam Cold Remedy Soft Chews32 in 1 CARTONTABLET, CHEWABLE321

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52642-232ZICAM COLD REMEDY SOFT CHEWS (ZINCUM ACETICUM, ZINCUM GLUCONICUM, CAFFEINUM) TABLET, CHEWABLE [BESTCO INC.]1Legacy NDC, 1 package rows20160224_2c85aa8b-eb85-0134-e054-00144ff8d46c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52642-23252642-232-32

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2c85aa8b-eb86-0134-e054-00144ff8d46c2c85aa8b-eb85-0134-e054-00144ff8d46c2016-02-24WarningsExact identifier
spl id: 2c85aa8b-eb86-0134-e054-00144ff8d46c
spl set id: 2c85aa8b-eb85-0134-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.